• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name bandage, liquid
510(k) Number K953131
Device Name EXUSORB STERILE ABSORBENT
Applicant
O.R. RESOURCES, INC.
212 BRINY AVE., SUITE A-4
POMPANO BEACH,  FL  33062
Applicant Contact ALFRED J LINDSEY
Correspondent
O.R. RESOURCES, INC.
212 BRINY AVE., SUITE A-4
POMPANO BEACH,  FL  33062
Correspondent Contact ALFRED J LINDSEY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received07/06/1995
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-